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K Number
K201307
Device Name
VisCalor
Manufacturer
VOCO GmbH
Date Cleared
2020-07-08

(54 days)

Product Code
EBF
Regulation Number
872.3690
Type
Special
Panel
Dental
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use
  • Class I to V restorations
  • Base in class I and II cavities
  • Reconstruction of traumatically damaged anteriors
  • Facetting of discoloured anteriors
  • Correction of shape and shade for improved aesthetic appearance
  • Locking, splinting of loose anteriors
  • Repairing veneers, small enamel defects and temporary C&B-materials
  • Extended fissure sealing
  • Restoration of deciduous teeth
  • Core build-up
  • Composite inlays
Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a dental restoration material called "VisCalor." It outlines the device name, regulation number, class, product code, and indications for use.

However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, or any of the other specific details requested in your prompt regarding a study proving a device meets acceptance criteria.

Therefore, I cannot fulfill your request using the provided input.

§ 872.3690 Tooth shade resin material.

(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.